§ 520.2075 Robenacoxib.

(a) Specifications. Each tablet contains: (1) 10, 20, or 40 milligrams (mg) robenacoxib for use in dogs; or (2) 6 mg robenacoxib for use in cats. (b) Sponsors. See sponsors in § 510.600(c) of this chapter. (1) No. 058198 for use of product described in paragraph (a)(1) and (a)(2) of this section as in paragraph (c)(1) and (c)(2) of this section. (2) No. 086117 for use of product described in paragraph (a)(2) of this section as in paragraph (c)(2) of this section. (c) Conditions of use—(1) Dogs—(i) Amount. Administer 0.91 mg/lb (2 mg/kg) orally, once daily, for a maximum of 3 days. (ii) Indications for use. For the control of postoperative pain and inflammation associated with soft tissue surgery in dogs weighing at least 5.5 lb (2.5 kg) and at least 4 months of age for a maximum of 3 days. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) Cats—(i) Amount. Administer 0.45 mg/lb (1 mg/kg) orally, once daily, for a maximum of 3 days. (ii) Indications for use. For the control of postoperative pain and inflammation associated with orthopedic surgery, ovariohysterectomy, and castration in cats weighing at least 5.5 lb (2.5 kg) and at least 4 months of age for a maximum of 3 days. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.